Erector Spinae Block in Segmental Mastectomy.

NCT ID: NCT03509090

Last Updated: 2019-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2019-05-31

Brief Summary

Erector spinae plane block (ESPB) is a recently described block. Although there is still no consensus of its mechanism, the published case series seems to promise a new regional anesthesia technique for both chronic and acute pain. In this clinical trial, the postoperative analgesic effect of ESPB will be studied in patients underwent unilateral breast cancer surgery.

Detailed Description

In this study 30 patients will be enrolled to study between March 2018-August 2018. All patient will be randomly selected who will be operated for breast cancer surgery between determined dates. Age, weight, ASA score, body mass index , additional dissease ststus will be recorded. The patients will be divided in two groups. One group will have ESPB at the end of the operation and the second group will be treated with multimodal analgesia techniques and both groups will receive patient controlled analgesia. Both groups will receive identical anaethesia protocols. Perioperative analgesia protocols will provide acetaminophen 1 gr and the same dose will be repeated in every 6 hours regardless of the pain scores. In postoperative period the pain scores of the patients will be recorded according to the numeric rating scale (NRS) in every three hours. If pain score raises over 4/10 on NRS the patient will receive tramadol 100mg as rescue analgesia. In case of persisting pain first, meperidine 50 mg will be apllied and other multimodal analgesic drugs will be added to protocol. At the end of the study 24 hours total opioid usage of patients, pain scores and side effects will statistically be analyzed.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ESP block group

Unilateral ESP block will be applied as postoperative regional analgesia technique in addition to the multimodal therapy. Then she is positioned in a right lateral position to perform ESP blocks. The skin will be disinfected and ESP block at one side will be performed in the lateral decubitus position and at T4 transverse process level by using 10-MHz linear ultrasound probe (Logic Ebook XP General Electrics, USA). The probe will be located 3 cm lateral to T4 spinous process in longitudinal parasagittal orientation. An 8 cm 21 gauge needle (BRAUN Stimuplex A®, Germany) will be inserted by using out of the plane technique. The ESP blocks proceed with 15 ml of 0,25% bupivacaine, 7,5 ml 1 % lidocaine, ,7,5 ml 0,9 % NaCl as total 30 ml . The injections will be applied after the confirmation of location by hidrodisection developed anterior to erector spinae muscle with 1-2 ml of local anesthetic solution.

Group Type: ACTIVE_COMPARATOR

erector spinae block

Intervention Type: PROCEDURE

erector spinae block will be performed in this group as postoperative analgesia treatment.

Control group

In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia prepared with tramadol. Patient-controlled analgesia (PCA) with tramadol at 3mg/cc concentration is programmed with no basal infusion, demand dose 10 mg and 20-minute lock-out interval. Also, patients received 1 gr paracetamol in every 6 hours.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: PROCEDURE

patients will receive only multimodal analgesic treatment including patient-controlled analgesia

Interventions

erector spinae block

erector spinae block will be performed in this group as postoperative analgesia treatment.

Intervention Type: PROCEDURE

Control group

patients will receive only multimodal analgesic treatment including patient-controlled analgesia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Being volunteer

2. Over 18 years old

3. Unilateral segmental mastectomy patients

Exclusion Criteria

1. Emergency operations

2. Younger than 18 years old,

3. Non Volunteers

4. ASA 3 and 4 patients

5. Non-cooperative patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maltepe University

OTHER

Sponsor Role: lead

Responsible Party

Onur Selvi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maltepe University Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Onur Selvi, Dr

Role: CONTACT

prostel@yahoo.com

02164440620 ext. 2018

References

Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

Reference Type: BACKGROUND

PMID: 28188621 (View on PubMed)

Bonvicini D, Giacomazzi A, Pizzirani E. Use of the ultrasound-guided erector spinae plane block in breast surgery. Minerva Anestesiol. 2017 Oct;83(10):1111-1112. doi: 10.23736/S0375-9393.17.12015-8. Epub 2017 May 11. No abstract available.

Reference Type: RESULT

PMID: 28492298 (View on PubMed)

Other Identifiers

17-AKD-186

Identifier Type: -

Identifier Source: org_study_id